2. Bone fractures:... the majority of the committee concluded that the MCLG is not likely to be protective against bone fractures.

Size: px

Start display at page:

Download "2. Bone fractures:... the majority of the committee concluded that the MCLG is not likely to be protective against bone fractures."

Randell Russell
5 years ago
Views:

1 Fluoride Action Network The Pesticides Project 82 Judson Street, Canton NY Tel: Food and Drug Administration Docket No. FDA-2008-N-0040 Regulatory Information Number (RIN) 0910-ZA30 (Old Docket No. 2006N-0168) April 30, 2008 Confusion over defining fluoride as a nutrient may be understandable due to the Institute of Medicine s (IOM) 1997 report Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride. However, one year after that report was published, clarification was made in a November 20, 1998, letter, signed by both Bruce Alberts, President of the National Academy of Sciences, and Kenneth Shine, President of the Institute of Medicine, to Albert W. Burgstahler, Ph.D. and others. Alberts and Shrine state: Nowhere in the report [Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride] is it stated that fluoride is an essential nutrient. If any speaker or panel member at the September 23rd [1997] workshop referred to fluoride as such, they misspoke. As was stated in Recommended Dietary Allowances 10th Edition, which we published in 1989: "These contradictory results do not justify a classification of fluoride as an essential element, according to accepted standards. Nonetheless, because of its valuable effects on dental health, fluoride is a beneficial element for humans. (Ref 1) Since the IOM report in 1997, the National Research Council of the National Academies (NRC) published Fluoride in Drinking Water: A Scientific Review of EPA's Standards in 2006 (Ref 2). This report stated that the current Maximum Contaminant Level Goal (MCLG) of 4 mg/l fluoride in drinking water is not protective of human health and requested the US EPA Office of Drinking Water to perform a risk assessment to determine a safe level. The three adverse health effects that the Committee based its opinion are: 1. Clinical Stage 2 skeletal fluorosis: associated with chronic joint pain, arthritic symptoms, calcification of ligaments, and osteosclerosis of cancellous bones... the committee judges that stage II is more appropriately characterized as the first stage at which the condition is adverse to health. Thus, this stage of the affliction should also be considered in evaluating any proposed changes in drinking-water standards for fluoride. (pages ) 2. Bone fractures:... the majority of the committee concluded that the MCLG is not likely to be protective against bone fractures. (page 3) 3. Severe Dental Fluorosis: After reviewing the collective evidence, including studies conducted since the early 1990s, the committee concluded unanimously that the present MCLG of 4 mg/l for fluoride should be lowered. Exposure at the MCLG clearly puts children at risk of developing severe enamel fluorosis... (page 2) (Ref. 2)

2 A major concern about fluoride is that it bioaccumulates in the human body (preferentially in the bone, but also in other organs) and has an estimated very long half-life. According to the NRC Report of 2006 (Ref 2): Subsequent decreases in exposure cause fluoride to move back out of bone into body fluids, becoming subject to the same kinetics as newly absorbed fluoride Twenty years might not represent a true half-life. Recent pharmacokinetic models (see below) are nonlinear, suggesting that elimination rates might be concentration dependent (My emphasis; page 92) The NRC Report of 2006 (Ref 2) documents the subsets highly likely to being over-exposed to fluoride. The Report states: Highly exposed subpopulations include individuals who have high concentrations of fluoride in drinking water, who drink unusually large volumes of water, or who are exposed to other important sources of fluoride. Some subpopulations consume much greater quantities of water than the 2 L per day that EPA assumes for adults, including outdoor workers, athletes, and people with certain medical conditions, such as diabetes insipidus. On a per-body-weight basis, infants and young children have approximately three to four times greater exposure than do adults. Dental-care products are also a special consideration for children, because many tend to use more toothpaste than is advised, their swallowing control is not as well developed as that of adults, and many children under the care of a dentist undergo fluoride treatments. (Ref 2, page 3) Based on analytical data from 16 states, EPA (2003a) estimates that million people nationally are served by public water supplies with fluoride concentrations exceeding 2 mg/l; of these 118, ,000 people receive water with fluoride concentrations greater than 4 mg/l. (Ref 2, Page 25, Note 2) Thus, certain subsets of the population, need to be protected from any additional sources of fluoride. To this end, the public needs the FDA to mandate labels that list the fluoride content of all beverages (including beer and wine) and commercial food. SULFURYL FLUORIDE: US EPA S HIGHEST TOLERANCES FOR FLUORIDE IN FOOD WERE APPROVED IN 2004 DUE TO THE USE OF THIS PESTICDE FUMIGANT On January 23, 2004, the US EPA s Office of Prevention, Pesticides, and Toxic Substances (OPPTS) approved the highest fluoride tolerances in and/or on food in its history due to the use of the pesticidal fumigant sulfuryl fluoride on post-harvest food. US EPA s OPPTS health risk assessment for sulfuryl fluoride was based solely on the Maximum Contaminant Level Goal of 4 mg/l fluoride in drinking water (Ref 3). Two years later, the NRC s 2006 report concluded that the MCLG of 4 mg/l fluoride in drinking water was not protective of human health. As stated in a March 22, 2006, news release by the National Academies (Ref 4): The U.S. Environmental Protection Agency's standard for the maximum amount of fluoride allowed in drinking water -- 4 milligrams of fluoride per liter of water -- does not protect against adverse health effects, says a new report from the National Academies' National Research Council. The fluoride tolerances approved by US EPA OPPTS in 2004 include, but are not limited to: 125 ppm - Wheat, flour, postharvest 130 ppm - Wheat, germ, postharvest 130 ppm - Wheat, milled byproducts, postharvest 2

3 SULFURYL FLUORIDE: US EPA APPROVED A 70 PPM FLUORIDE TOLERANCE FOR PROCESSED FOOD, WITH A FEW EXCEPTIONS On July 15, 2005, US EPA OPPTS approved very high tolerances for ALL processed foods (and spices) due to the use of sulfuryl fluoride as a fumigant. It should be noted that the NRC Report of 2006 did not include the very high tolerances of 70 ppm fluoride approved for processed foods in With the exception of the following specified commodities, the tolerance for processed foods is 70 ppm fluoride (Ref. 5). 40 ppm - Cattle, meat, dried 5.0 ppm Cheese 20 ppm - Cocoa bean, postharvest 40 ppm - Coconut, postharvest 15 ppm - Coffee, postharvest 20 ppm Ham 5.0 ppm - Milk, powdered 40.0 ppm - Millet, grain, postharvest 20 ppm - Nut, pine, postharvest 15 ppm - Peanut, postharvest 20 ppm - Rice flour, postharvest SULFURYL FLUORIDE: LEVELS OF FLUORIDE IN DRIED EGGS USED IN PROCESSED FOOD IS UNKNOWN In its July 15, 2005, ruling, US EPA OPPTS approved a tolerance of 900 ppm for Eggs, dried (Ref 5). However, US EPA OPPTS revoked this tolerance in January 2006 (Ref 6), without sufficient clarification for the public to estimate, or know, the level of fluoride in processed food that contain dried eggs. EPA OPPTS stated: Generally, commodities with higher protein and/or fat content have higher residues of sulfuryl fluoride or fluoride (an extreme case being powdered eggs). [Page 22) HED has not included dried eggs in dietary exposure and risk estimates associated with food fumigations, and is recommending that food fumigation of dried eggs be removed from the label section titled "Commodities That Can Be Fumigated." Dow AgroSciences has submitted a draft label making that change. Incidental treatment of dried eggs resulting from space fumigations may be permitted. (My emphasis; Page 30.) SULFURYL FLUORIDE; LEVELS OF FLUORIDE IN EDIBLE OILS IN PROCESSED FOODS FROM FUMIGATION WITH SULFURYL FLUORIDE IS UNKNOWN. The public also does not know what fluoride levels may be present in edible oils present in processed foods fumigated with sulfuryl fluoride. According to US EPA OPPTS (Ref. 6): HED has not included edible oils in dietary exposure and risk estimates associated with food fumigations, and is recommending that the label be modified to state that edible oils may not be directly fumigated. Incidental treatment of edible oils resulting from space fumigations may be permitted. (My emphasis; Page 30.) The Fluoride Action Network together with the Environmental Working Group and Beyond Pesticides, have submitted Objections to US EPA OPPTS in 2004 and 2005 on these fluoride tolerances (for more detail, see Ref 7). 3

4 CRYOLITE: FLUORIDE TOLERANCES FROM THE USE OF THIS PESTICIDE US EPA OPPTS approved the following fluoride tolerances from the use of the pesticide cryolite: 7 ppm Apricot 7 ppm Blackberry 7 ppm - Blueberry (huckleberry) 7 ppm Boysenberry 7ppm Broccoli 7 ppm - Brussels sprouts 7 ppm Cabbage 7 ppm Cauliflower 7 ppm Collards 7 ppm Cranberry 7 ppm Cucumber 7 ppm Dewberry 7 ppm Eggplant 7 ppm - Fruit, citrus 7 ppm Grape 7 ppm Kale 7 ppm Kohlrabi 7 ppm Lettuce 7 ppm Loganberry 7 ppm Melon 7 ppm Nectarine 7 ppm Peach 7 ppm Pepper 7 ppm - Plum, prune, fresh 7 ppm Pumpkin 7 ppm Raspberry 7 ppm - Squash, summer 7 ppm - Squash, winter 7 ppm Strawberry 7 ppm Tomato 7 ppm - Youngberry All fluoride tolerances approved by US EPA OPP are available at: Sincerely, Ellen Connett, Director, The Pesticides Project for Fluoride Action Network References: 1. Alberts B. and Shine, K. (1998). Letter to Albert W. Burgstahler, PhD, and others. November 20. Online at: 2. National Research Council of the National Academies (NRC). (2006). Fluoride in water: a scientific review of EPA's standards. The National Academies Press, Washington, DC. Online at 4

5 3. US EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS). (2004). Sulfuryl fluoride; pesticide tolerance. Final rule. Federal Register. January 23. Online at 4. National Academies. (2006). EPA Standard for Fluoride in Drinking Water Is Not Protective;Tooth Enamel Loss, Bone Fractures of Concern at High Levels. News Release. March 22. Online at 5. US EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS). (2005). Sulfuryl fluoride; Pesticide Tolerance. Final Rule. Federal Register. July 15. Online at 6. US EPA Office of Prevention, Pesticides, and Toxic Substances (OPPTS). (2006). Human Health Risk Assessment for Sulfuryl Fluoride and Fluoride Anion Addressing the Section 3 Registration of Sulfuryl Fluoride as a Fumigant for Foods and Food Processing Facilities. PP# 3F6573. January 18. Online at 7. At the request of EPA, the groups submitted a consolidation of their Objections in November This submission is the most succinct representation of the groups' arguments for EPA to grant them an evidentiary hearing. Online at 5

Proposed Revision or Revocation of Maximum Residue Limits for Discontinued Agricultural Pest Control Products: Update 2

Proposed Maximum Residue Limit PMRL2018-44 Proposed Revision or Revocation of Maximum Residue Limits for Discontinued Agricultural Pest Control Products: Update 2 (publié aussi en français) 8 November